for people ages 2-17 (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Sofia Verstraete
Headshot of Sofia Verstraete
Sofia Verstraete



Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.

Study periods for the intervention-specific appendix (ISA) will be as follows:

  • A 12-week induction period
  • A maintenance period from Week 12 to Week 52, and
  • A safety follow-up period up to 16 weeks.

The study will last about 74 weeks and may include up to 19 visits.

Official Title

A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease


Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.


Crohn's Disease, Inflammatory Bowel Disease, Crohn Disease, Mirikizumab


You can join if…

Open to people ages 2-17

  • Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
  • Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
  • Participants must have endoscopy with evidence of active CD defined as as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study.
  • Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

You CAN'T join if...

  • Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
  • Participants must not have an abscess.
  • Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.


  • UCSF-Mission Bay accepting new patients
    San Francisco California 94143 United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • University of California San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSF

  • Sofia Verstraete
    Associate Professor, Pediatrics, School of Medicine. Authored (or co-authored) 28 research publications


accepting new patients
Start Date
Completion Date
Eli Lilly and Company
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY)
Phase 3 research study
Study Type
Expecting 90 study participants
Last Updated